Photocure ASA · OSL:PHO
Photocure ASA — Q2 2002 Earnings Presentation
22 slides from Photocure ASA's earnings presentation, August 2002
Slide 1: PhotoCure ASA Results 2nd quarter 2002
PhotoCure ASA Results 2nd quarter 2002 August 2002
Slide 2: Highlights
Highlights Metvix® – Commercialisation on track – Positive clinical data in treatment of nodular BCC achieved in US Hexvix® – On track for filing of marketing authorisation first half 2003 Benzvix® – Clinical pilot studies on track AlpharadinTM – PhotoCure has acquired shares and share optio
Slide 3: Marketing Metvix - Number of clinics
Marketing Metvix® –Commercialisation in the Nordic area on track Clinics with PhotoCure lamps 100 Number of clinics 80 Finland 60 Denmark 40 Norway Sweden 20 0 Febr. 02 May 02 Aug. 02
Slide 4: Marketing Metvix - Number of light sources
Marketing Metvix® –Commercialisation in the Nordic area on track Number of light sources 140 120 100 Finland 80 Denmark 60 Norway 40 Sweden 20 0 Febr. 02 May 02 Aug. 02
Slide 5: Marketing Metvix - Commercialisation in Sweden
Marketing Metvix® –Commercialisation in Sweden Regulatory approval June 2001 Reimbursed price of 1300 SEK per tube of Metvix® October 2001 Procedure fee negotiations ongoing Target group: 120 dermatology centres Training personnel from 78 centres – 46 centres completed – 32 centres to be t
Slide 6: Marketing Metvix - Commercialisation in Norway
Marketing Metvix® –Commercialisation in Norway National approval February 2002 Approved price of 1100 NOK per tube of Metvix® Reimbursement application filed for Metvix® Target group: 85 dermatology centres Provided 34 centres with 50 light sources Training of centres ongoing
Slide 7: Marketing Metvix - Commercialisation in Denmark
Marketing Metvix® –Commercialisation in Denmark Metvix® commercially available July 2002 Single patient reimbursement available Procedure fee negotiations ongoing Metvix® priced at 1100 DKK per tube Target group: 90 dermatology centres Market introduction symposium held in May Training
Slide 8: Marketing Metvix - Commercialisation in Finland
Marketing Metvix® –Commercialisation in Finland National approval May 2002 Target group: 100 dermatology centres – 5 University hospitals established Reimbursement application filed for Metvix® Metvix® priced at 148 Euro per tube Market introduction symposium held in May Training of cent
Slide 9: Metvix - Marketing Authorisations in several countries
Metvix® – Marketing Authorisations in several countries National authorisations issued in: – Sweden, Norway, Denmark, Finland, Iceland, Germany, UK, Ireland, Luxembourg, Greece, New Zealand Awaiting national authorisations in: – Belgium, Austria, Spain, Italy Application pending in Switzerland
Slide 10: Metvix - Strong clinical data achieved in USA
Metvix® – Strong clinical data achieved in USA Nodular BCC complete response rate 100 % 90 % 80 % 70 % 60 % 50 % 40 % 30 % 20 % 10 % 0% All areas Facial lesions Lesion area and a margin fully examined under microscope
Slide 11: Marketing Metvix - Galderma pre-launch preparations ongoing
Marketing Metvix® – Galderma pre-launch preparations ongoing Several meetings held between Galderma and PhotoCure executives on three continents Several Steering Committee meetings held Galderma hired dedicated management resources Galderma task force established – More resources allocated t
Slide 12: New indications in dermatology - Several possible indications
New indications in dermatology – Several possible indications Positive data on acne – Pilot study completed – World wide acne market totals 1.7 bn USD per year Other areas of interest – Photoaging (skin rejuvenation) – Transplant patients – Wound healing (pilot study planned) – Viral diseases
Slide 13: Hexvix preparation
Hexvix® preparation Hexyl aminolevulinate powder + Phosphate buffer saline 50 mL ± Hexvix® solution - Instilled 1 hour in the bladder - Start cystoscopy within 30 minutes
Slide 14: Hexvix in bladder cancer - positive results in phase II clinical trial
Hexvix® in bladder cancer – positive results in phase II clinical trial Four times more patients with CIS lesions detected (CIS = Carcinoma in Situ) Hexvix® White light 12 / 13 92% 3 / 13 23% Patients have one or more CIS lesions
Slide 15: Hexvix - phase III program ongoing
Hexvix® – phase III program ongoing Europe – Enrolment in first clinical phase III study completed - Interim data confirm the positive phase II results – One additional study initiated USA – Investigational New Drug status obtained – Phase III studies initiated First marketing application plan
Slide 16: Hexvix - pre-marketing activities ongoing
Hexvix® – pre-marketing activities ongoing Contract manufacturer selected Market research study completed Price and reimbursement preparations ongoing Out-licensing activities initiated – PhotoCure will at least retain the Nordic region
Slide 17: Research and development - strong pipeline
Research and development – strong pipeline ALA derivatives R&D opportunities (excluding dermatology and urology) Barrets oesophagus – clinical pilot study initiated Colo-rectal cancer – clinical pilot study initiated Lesions in mouth, pharynx and larynx Gynaecology (vulva, cervix, ovarian)
Slide 18: Research and development - Alpharadin for bone metastasis
Research and development – AlpharadinTM for bone metastasis AlpharadinTM is being developed by Anticancer Therapeutic Inventions AS (ATI) – PhotoCure owns 6.6% of ATI – Share options to increase ownership to more than 60% AlpharadinTM – A bone metastasis-seeking radio pharmaceutical – A new conc
Slide 19: PhotoCure - important milestones the next twelve months
PhotoCure – important milestones the next twelve months As of May 2002 Metvix® Expand the number of clinics in the Nordic countries – 150 clinics with light sources Submit additional clinical data in Australia, France, Portugal & Holland File new drug application for BCC in the US Initiate c
Slide 20: PhotoCure - important milestones the next twelve months
PhotoCure – important milestones the next twelve months As of May 2002 Hexvix® Complete current ongoing phase III studies for bladder cancer detection File first marketing authorisation application for bladder cancer detection Start clinical pilot study on treatment of bladder cancer Benzvix®
Slide 21: Financial Statements - Profit & Loss
Financial Statements – Profit & Loss Three months ended Six months ended 30.06.2002 30.06.2001 All figures in NOK 1,000 30.06.2002 30.06.2001 4 594 529 Sales 8 291 931 6 2 061 Other revenues 130 2 686 4 601 2 590 Total operating revenues 8 422 3 617 1 028 5 545 Salaries & other pers. costs 4 874 10
Slide 22: Financial statements - Balance sheet
Financial statements - Balance sheet Figures in NOK 1,000 30.06.2002 31.12.2001 Fixed assets 11 413 3 935 Receivables 24 181 10 456 Securities 221 229 283 564 Cash and bank deposits 83 930 21 614 Total assets 340 752 319 569 Shareholders' equity 206 212 259 398 Long term liabilities 17 524 17 362 Cu